Clinical Trials in China / NCT06378242
Recruiting
Phase 1/2
To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2
NCT06378242 · tracked via the Priya Life Science China tracker
Condition(s) studied
High-risk Non-muscle Invasive Bladder Cancer
Investigational drug(s) / intervention(s)
Disitamab Vedotin for injection: Intravesical instiliations into the bladder
Study summary
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2
Eligibility
Inclusion Criteria:
1. Voluntary consent to participate in the study and signed the informed consent form.
2. Male or female, age 18-75 years (including both).
3. Histologic confirmed non-muscle invasive bladder urothelial carcinoma (NMIBC), and the risk group met the high-risk (including very high-risk) group.
Note: High-risk NMIBC is a high-grade / G3 tumor meeting any of the following:
a.Carcinoma in situ (CIS) b. T1 stage c. diameter\>3cm d.Multiple tumors, or recurrent tumors.
4. Absence of resectable disease(Ta and/or T1 disease) after transurethral resection (TURBT) procedures (residual CIS acceptable;
5. The urologist assessed that radical surgery for bladder cancer was not suitable or the subject refused radical surgery for bladder cancer.
6. Tumor tissue samples were detected by immunohistochemistry (IHC) to satisfy HER2 expression of 1+, 2+ or 3+.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
8. Adequate heart, bone marrow, liver, kidney and coagulation function
Exclusion Criteria:
* 1\. Invasive bladder cancer (T2 and above) and / or with regional lymph node and distant metastasis.
2\. Combined urothelial carcinoma outside the bladder (i. e., urethra, ureter or renal pelvis).
3\. Any other antitumor therapy received within 4 weeks before study administration, .
4 Subjects plan to undergo major surgery during the study or within 4 weeks before the first dose.
5, Known allergic to DV and its components or to any excipients.
Primary outcome measure(s)
- Incidence of dose-limiting toxicity(DLT) (Phase I) — Approximately 21 days
- Incidence of Adverse event (Phase I) — Approximately 1 years
According to the NCI CTCAE V5.0, to evaluate safety including adverse event rate and adverse event grade - Recommended Phase II Dose(RP2D) — Approximately 21 days
Assessed based on the Incidence of DLT - Maximum Tolerated Dosage(MTD) — Approximately 21 days
Assessed based on the Incidence of DLT
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Sun Yat-sen Memorial Hospital,SunYat-sen University | Guangzhou | Guangdong | Recruiting |
| Tongji Hospital | Wuhan | Hubei | Not Yet Recruiting |
| Hunan Cancer hospital | Changsha | Hunan | Recruiting |
| The first affiliated hospital with nanjing medical universtity | Nanjing | Jiangsu | Not Yet Recruiting |
| West China Hospital | Chengdu | Sichuan | Not Yet Recruiting |
| Tianjin Medical University Second Hospital | Tianjin | Tianjin Municipality | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06378242 on ClinicalTrials.gov ↗ ← All trials in China